A Phase II Trial of R435(Bevacizumab) in chemotherapy naive and inoperable malignant pleural mesothelioma patients
Phase 2
Completed
- Conditions
- chemotherapy naive and inoperable malignant pleural mesothelioma
- Registration Number
- JPRN-jRCT2080223239
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Bevacizumab plus cisplatin/pemetrexed was well tolerated in Japanese patients with chemotherapy-naive and unresectable malignant pleural mesothelioma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
ECOG Performance status 0 ot 2
- Histologically confirmed malignant pleural mesothelioma which is inoperable
- chemotherapy naive (including pre or post operative adjuvant chemotherapy)
- Identifiable tumor image present
Exclusion Criteria
- History of anti-tumor therapy(chemotherapy, Immunotherapy or biotherapy)
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abcess in the last 6 months
- Clinical symptoms accompanying or treatment requiring metastasis to central nervous system
- History of cerebral vascular accident or transient ischemic attack in the last 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method other<br>other (Tolerability)<br><br>CTCAE (ver 4.03)
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>CTCAE ver 4.03, RECIST ver 1.1